This early phase I clinical trial recombinant interferon alfa-2b (IFN a2b) or pegylated interferon alfa-2b (PEG-interferon alfa-2b) in treating patients with melanoma undergoing sentinel lymph node biopsy. Biological therapies, such as recombinant interferon alfa-2b and PEG-interferon alfa-2b may kill tumor cells by stopping blood flow to the tumor and by stimulating white blood cells to kill tumor cells. It is not yet known whether interferon alfa-2b is more effective than PEG-interferon alfa-2b in treating melanoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00871533.
PRIMARY OBJECTIVES:
I. To utilize gene-profiling analysis of regional lymph node tissue to molecularly characterize the effect of interferon (IFN) α2b and PEG IFNα2b on the sentinel lymph node (SLN).
SECONDARY OBJECTIVES:
I. To quantitate by Taqman Real Time polymerase chain reaction (PCR) (QRT-PCR) putative biomarkers differentially expressed in the SLN for each active treatment group (as compared to control), and among all active treatment groups combined.
II. To utilize gene-profiling analysis of regional lymph node tissue, to molecularly characterize the effect of perilesional IFN α2b and PEG IFNα2b administered as close as possible to the primary tumor site on SLNs that are positive vs. negative for tumor micrometastases.
OUTLINE: Patients are randomized to 1 of 5 treatment groups.
ARM I: Patients receive recombinant interferon alfa-2b intravenously (IV) daily on days -14 to -10 and days -7 to -4. Patients undergo SLN biopsy on day 0.
ARM II: Patients receive recombinant interferon alfa-2b subcutaneously (SC) peri-lesionally (PL) on days -14, -12, -10, -7, -5, and -3. Patients undergo SLN biopsy on day 0.
ARM III: Patients receive PEG-interferon alfa-2b SC systemically on days -14 and -7. Patients undergo SLN biopsy on day 0.
ARM IV: Patients receive PEG-interferon alfa-2b SCPL on days -14 and -7. Patients undergo SLN biopsy on day 0.
ARM V: Patients undergo SLN biopsy on day 0.
After completion of study treatment, patients are followed up at 3-4 weeks, 3 months, and up to 5 years.
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorAhmad Tarhini